Intervertebral Body Fusion Device - India CDSCO Medical Device Registration

Intervertebral Body Fusion Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_aeafe6ff581a8bec1520a9376aefcd5f. This device is marketed under the brand name Mastergraft Granules. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Intervertebral Body Fusion Device

UID: IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_aeafe6ff581a8bec1520a9376aefcd5f

Brand Name

Mastergraft Granules

License Holder

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class C

Approving Authority

CDSCO

Product Information

The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with degenerative disc disease (Mastergraft Granules) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Certain sizes of the CLYDESDALE® Spinal System may be used with INFUSE® Bone Graft in single-level Oblique Lateral Interbody Fusion (Mastergraft Granules) procedures from L2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the CLYDESDALE® Spinal System approved for use with INFUSE® Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE® Bone Graft. INFUSE® Bone Graft is not indicated for use in a direct lateral interbody fusion (Mastergraft Granules) surgical approach. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. INFUSE® Bone Graft is not indicated for use in patients with this condition. These patients should be skeletally mature and have had six months of non-operative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach

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Other Products from India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

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